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Ready, Set, Submit … Electronically

February 26, 2015 | Kathy Elks, RAC, Associate Director, Regulatory Operations | Regulatory Operations

Our clients often ask when the FDA will require all regulatory submissions to be submitted electronically, in eCTD format. And now we have an answer. Sort of.

FDA recently finalized a guidance document that sets the stage for this upcoming requirement.

changeBackground
The FDA Safety and Innovations Act (FDASIA) of 2012 amended the FD&C Act by adding Section 745A, which addresses electronic submissions. The law states that certain NDA, ANDA, BLA, and IND submissions must be submitted to the FDA in electronic format, according to a timeframe to be determined by the FDA.

“May” Becomes “Must”
In the law, Congress granted FDA authorization to implement the statutory requirements via issuance of guidance documents, as opposed to rule (regulation) making. Therefore, upcoming guidance documents related to electronic submissions will not contain the typical language such as “may” or “should” but instead will have “binding” terms such as “must” and “required.”

The “Mother” Guidance
FDA concluded that it would not be feasible to describe and implement the electronic formats applicable to all submissions covered under Section 745A within one guidance document.

Therefore, they started by releasing a general (“mother”) guidance document in December of 2014 that outlines the submission types that must be submitted electronically, the exemptions from filing electronic submissions, waiver criteria, and the timetable and process for implementation.

The guidance applies to new NDA, ANDA, BLA, and IND submissions, as well as all subsequent submissions, including amendments, supplements, and reports.

The First Date is Set
The timeline for mandatory electronic submissions will begin no earlier than 24 months after issuance of the final guidance specifying an electronic submission format for a particular type of data.

For example, the FDA has already finalized its guidance on submissions of standardized study data. All studies with a start date after December 2016 must submit study data electronically using the appropriate FDA-supported standards, formats, and terminologies.

Are You Ready?
Companies that have not converted to eCTD should be proactive and start planning and budgeting for these changes now.

readyMigrating from paper submissions to eCTD submissions requires strategic planning and impacts many business processes within a company. Companies need to evaluate their document authoring practices to ensure their documents are written in the correct eCTD granularity. It may be beneficial to consider purchasing a suite of commercially available authoring templates to aid in this.

In addition to implementing appropriate document authoring processes, internal procedures are needed for document review and approval. Your company may need an electronic document management system to manage the archival, review, and approval of regulatory submission documents. Furthermore, software is needed to create and publish an eCTD submission. Many eCTD applications are commercially available.

Available Options
Some eCTD software vendors also offer SaaS (software as a service) as an alternative to having an “in-house” installation. For both in-house and SaaS implementations, the software must be tested and maintained to meet agency regulations. However, the most important need for a successful eCTD program is a staff of skilled and experienced submission managers and publishers.

BudgetThe timeline for mandatory electronic submissions is rapidly approaching. The costs for transitioning to the eCTD can be a barrier for smaller companies with limited resources. The capital costs for implementing an eCTD program can range from $250,000 – $500,000 including the expenses for purchasing and validating the software. In addition, annual costs for maintaining eCTD systems can range from $100,000 – $300,000.

Given the financial commitment that is needed to establish an eCTD program, outsourcing the eCTD publishing to a CRO provider is a good solution for smaller pharmaceutical companies. Outsourcing is also a good option for larger pharmaceutical companies that may need to augment their staff during peak submission times.

Need Help?
IMPACT has a Regulatory Operations group that can help you convert your paper submissions to eCTD format. We have eCTD authoring templates, a 21 Part 11 compliant electronic document management system, and an experienced team to help you through the document authoring and regulatory submission process.

Whether you have a quick question or you would like to discuss your specific needs in detail, please send us an email or give IMPACT a call today at (919) 899-9248. We’d love to help you!kathy

Category: Regulatory Operations
Keywords: eCTD, electronic submissions, FDA guidance document, eCTD deadline, publishing software, NDA, IND, BLA, ANDA

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